a. Field of the Invention
The present invention relates generally to methods for treatment of soft tissue diseases, and, more particularly, to a therapy for treatment of soft tissue disease states and related conditions by application of a combination of an antibiotic agent and a mobilizing gel or other carrier for penetrating the tissue.
b. Background and Related Art
As used herein, the term “soft tissue disease” refers to inflammations and other pathological conditions affecting musculoskeletal tissues and other soft tissues of the body, which are referred to from time to time herein as sub-dermal tissues so as to distinguish them from dermal conditions. Just a few examples of such conditions involving musculoskeletal tissues include tendonitis, synovitis, tenosynovitis, myositis and arthritis. Such conditions may develop naturally or may be the result of strain or other trauma, and typically manifest themselves in the form of pain, stiffness, and similar symptoms.
As part of the present invention, it is hypothesized that some such soft tissue disease conditions may either result from or be aggravated by chronic or acute microbial infections involving the affected tissues. Research has correlated a high incidence of Mycoplasma to tendonitis and synovitis in poultry, and has shown the relationship between the presence of members of the Mycoplasma or Chlamydia families and other soft tissue diseases in poultry and other animals. Other research has demonstrated that Mycoplasmas are associated with the development of arthritis in swine and poultry (e.g., see Backman et al., Zeitschrift fur Rheumatologie, November-December 1983).
Data relating the presence of Mycoplasma/Chlamydia to soft tissue disease in humans is less available, owing in part to the relative difficulty of obtaining samples of tissue for analysis. Nevertheless, the scientific literature includes a number of studies documenting a high detection rate for bacterial DNA in certain types of human musculoskeletal disease, notably in arthritic joint fluid. It has also been found that many cases of severe acute lower back pain respond dramatically (e.g., overnight) to short-term treatment with an oral antibiotic specific to Chlamydia Pneumoniae, namely azythromycin. Three or so days following onset of the back symptoms, however, this effect was not seen. These observations are significant in that they are in keeping with the microbiology of Chlamydia Pneumoniae, which immediately after initial infection produces an abundance of lactic acid that is locally quite painful, and three days later produces a substance called Chlamydia Specific Heat Shock Protein (HSP), or HSP60 or HSP10. This substance causes the affected cells to produce altered lipids which are flammatory and atherogenic.
This same basic sequence of infection has been seen to occur in other organs and systems in the body, including in connection with the coronaries, carotid arteries and aortic aneurysms. Other research, particularly in Europe, has provided evidence regarding the involvement of Chlamydia Pneumoniae infections in arteriosclerosis, and these same bacteria has been strongly implicated in Alzheimer's Disease and multiple sclerosis.
As part of the present invention, Applicant has found that a large number of patients receiving orthopedic treatment for chronic severe lower back pain or tendonitis test positive for Chlamydia Pneumoniae, either by positive PCR (bacterial gene detection) of the peripheral blood or by specific serum antibodies to C. Pneumoniae. By way of background, it will be understood that Chlamydia Pneumoniae is a pathogenic obligate intracellular bacteria infecting through the upper respiratory system, which is responsible for approximately 5% of ambulatory pneumonia. It is not to be confused with Chlamydia Trachomatis, a totally different bacteria which is sexually transmitted and responsible largely only for genitourinary and ocular pathology.
In view of this evidence, Applicant has developed the non-binding hypothesis that one or more infectious micro-organisms, in particular, members of the Mycoplasma or Chlamydia families, may be responsible for precipitating or aggravating many forms of soft tissue disease, including musculoskeletal disease, and/or the pain and other symptoms which are associated therewith. As part of Applicant's hypothesis it is believed that the microbial activity takes place within the affected soft tissues themselves, and it is therefore a primary object of the present invention to provide a method by which the affected soft tissues are penetrated with a suitable antimicrobial agent so as to control or eradicate the infection at its origin.
As was noted above, some of these conditions (namely, chronic severe lower back pain) have responded to antibiotics that have been administered orally. While this may represent a suitable form of treatment in some instances, certain drawbacks inherent in the oral administration of antibiotics tend to limit the effectiveness of this approach. For example, oral administration of antibiotics can cause significant and sometimes life-threatening gastrointestinal side effects, especially in the case of the elderly and when administered in high dosages and over extended periods. Furthermore, oral administration of antibiotics can provide only systemic treatment, with no specificity as to the location of action, and is also comparatively slow in effect.
Antibiotics may also be administered by injection or intravenously, however, with conventional techniques the effect is again systemic rather than localized, and in any event such an approach is not normally suitable for home or self-administered treatment. Topical administration of antibiotics has also been proposed or used in some instances, but with penetration by the antibiotic being limited to the dermis, typically for treatment of acne, cuts, burns, infections, baldness, or other skin conditions or damage; such dermal applications would do nothing to reach and treat the sub-dermal soft tissue diseases described above.
Accordingly, there exists a need for a method and composition for treatment of soft tissue diseases and related conditions and disease states, by administration of one or more antimicrobial agents so as to control or eradicate microbial activity in the affected area. Furthermore, there exists a need for such a method and composition which avoid the gastrointestinal hazards and other side effects associated with oral administration of antibiotics. Still further, there exists a need for such a method and composition that permit treatment to be limited to a specific location or locations within the body. Still further, there exists a need for such a method and composition that provide quick penetration and action so as to minimize microbial progress in the affected area.